Indications

Sodium Hyaluronate is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e.g., acetaminophen. It may also be used as adjuvant in orthopaedic surgery.

Composition

Pharmacology

Sodium Hyaluronate is a viscous solution consisting of a high molecular weight fraction of purified natural sodium hyaluronate in buffered physiological sodium phosphate. It has a pH of 6.8-7.5. Hyaluronic acid is an important component of the body's extracellular matrix and is present in a particularly high concentration in cartilage and synovial fluid. Endogenous hyaluronic acid provides viscosity and elasticity to synovial fluid, which is fundamental for its lubricating and shock absorbing properties. It is essential for the correct structure of proteoglycans in articular cartilage. In osteoarthritis there is an insufficient amount and a change in the quality of hyaluronic acid in synovial fluid and cartilage. The intra-articular administration of hyaluronic acid into arthritic joints improves joint functions.

Dosage & Administration

Sodium Hyaluronate is administered by intra-articular injection. A treatment cycle consists of five injections given at weekly intervals. Some patients may experience benefit with three injections given at weekly intervals. Inject the full 2 ml in one knee only. If treatment is bilateral, a separate injection should be used for each knee. Treatment may be repeated, usually, at 6 up to 12-month interval. Pediatrics : The safety and effectiveness of Sodium Hyaluronate have not been demonstrated in children.

Contraindications

The drug is contraindicated in patients with known hypersensitivity to hyaluronate preparations. Intra-articular injections are contraindicated in cases of past and present infections or skin diseases in the area of the injection site to reduce the potential for septic arthritis.

Side Effects

Local reactions such as pain, swelling/effusion and warmth or redness at the injection site have been reported. Usually such symptoms are transient and disappear spontaneously within a few days by resting the affected joint and applying ice only.

Pregnancy & Lactation

The safety and effectiveness of Sodium Hyaluronate have not been established in pregnant women. It is not known if Sodium Hyaluronate is excreted in human milk. The safety and effectiveness of Sodium Hyaluronate have not been established in lactating mother.

Precautions & Warnings

Use caution when injecting Sodium Hyaluronate into patients who are allergic to avian proteins, feathers, and egg products. Strict aseptic administration technique must be followed. Remove joint effusion, if present, before injecting Sodium Hyaluronate. It is recommended that the patient avoid any strenuous activities or prolonged (i.e., more than 1 hour) weight-bearing activities such as jogging or tennis within 48 hours following the intra-articular injection.

Therapeutic Class

Drugs for Osteoarthritis

Storage Conditions

Hyronate injection should be stored in a cool (below 25° C) and dry place and protected from light. Protect from freezing.